A study of the safety of 3 months treatment with BIT225, in combination with pegylated interferon and ribavirin, in patients with chronic hepatitis C infection, compared to pegylated interferon and ribavirin alone, including measurement of the concentration of BIT225 in the blood and antiviral activity.

Exclusion Criteria37

• Received an investigational drug, immunomodulator, systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to Day 1.
• Positive results for Hepatitis B and/or HIV antibody at Screening.
• History or presence of other evidence of a medical condition associated with chronic liver disease.
• Bridging cirrhosis or cirrhosis confirmed on a liver biopsy, or ultrasound and fibroscan, obtained within the past 36 months as judged by a local pathologist.
• History or signs of decompensated liver disease.
• History or other evidence of clinically significant renal disease.
• Pregnancy or breast feeding, male partners of pregnant females.
• Abnormal haematological and biochemical parameters within 60 days of Entry:
• a. Absolute neutrophil count <1000/mm^3
• b. Haemoglobin <12 g/dL in females or 13 g/dL in males
• c. Platelet count <150,000/mm^3
• d. International normalized ratio (INR) >1.5
• e. Total bilirubin > 1.5 times the normal reference range
• f. Creatinine > 1.5 mg/dL
• Estimated creatinine clearance < 60 mL/minute at Screening. Value will be calculated using the Cockcroft-Gault formula.
• Screening ECG QTcB value > 450 ms.
• The consumption / administration of excluded concomitant medication (prescribed, over-the-counter or complementary) at the time of the Screening visit.
• Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
• A positive result on urine screen for drugs of abuse at Screening or Day 1.
• History of severe psychiatric disease, or depression which in the opinion of the Investigator could be exacerbated by IFN therapy. Uncontrolled or active depression or other psychiatric disorder such as untreated Grade 3 or higher psychiatric disorder, Grade 3 or higher disorder not amenable to medical intervention, or any hospitalization within the past 52 weeks that in the opinion of the site Investigator might preclude tolerability of study requirements.
• Any prior suicide attempt.
• History of immunologically mediated disease that may be exacerbated by interferon use.
• History or other evidence of chronic pulmonary disease associated with functional limitation.
• History of documented or presumed coronary artery disease or cardiovascular disease, clinically significant arrhythmia.
• History of a severe seizure disorder or current anticonvulsant use.
• History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
• Evidence of an active or suspected cancer or a history of malignancy within 2 years of the study.
• History of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• Active thyroid disease.
• Any patient with a baseline increased risk for anaemia or for whom anaemia would be medically problematic.
• History or other evidence of severe retinopathy.
• Serious illness requiring systemic treatment and/or hospitalization until the participant either completes therapy or is clinically stable on therapy, in the opinion of the site Investigator, or at least 7 days prior to study entry.
• Known allergy/sensitivity or any hypersensitivity to components of study drug or its formulation.
• Unable to refrain from smoking during the PK evaluation periods of the trial, if enrolled in the PK sub-study.
• Difficulty abstaining from grapefruit, starfruit, and pomelo including, products containing these fruit, from 7 days prior to the first dose of investigational product until the end of the dosing period.
• Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
• Current use of herbal medications or unwillingness to cease use during study participation.